Sohan CHITLANGE, Harshad KAPARE, Kaveri AHER, Shivaji AHER

Development of novel formulation technology for oral delivery of Sterculia Gum

Constipation and associated health issues like acid reflux, malnutrition were commonly observed in regions with water availability limitations. Although some of the products available in the market address this issue, there is limited research on development of such products which will be able to solve multiple associated issues. Sterculia gum, a natural product known for water retention and associated properties in traditional systems of medicine. Despite this, research and therapeutic applications of this product are in infancy. This study was aimed to develop laxative oral granules of sterculia gum with some other therapeutically and nutraceutical active ingredients for multiple applications as bulk laxative, demulcent, water retention agent, diarrhea and appetite controller in the management of obesity. Sterculia gum, magnesium trisilicate, dried magnesium sulphate, heavy kaolin and excipients characterization and product development was carried out with developed in house formulation technology. Developed formulation was evaluated for various formulation based evaluation parameters. Desirable pH range of 4.3 to 6.9 was observed indicating reduction in acidic properties of sterculia gum; good swelling index was observed 240ml/3gm. Identification tests and assay of active ingredients were carried and found to be within specified limit range. Developed formulation showed desirable stability of 12 months indicating good shelf life of product. Study results revealed developed formulation can be further investigated in clinical studies and might be served as novel dosage form for therapeutic applications in habitual constipation for multiple therapeutic targets with single product.

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[1] Setia A, Goyal S, Goyal N. Applications of gum karaya in drug delivery systems: a review on recent research. Der Pharmacia Lettre. 2010; 2(5):39-48
[2] http://www.fao.org/3/a0675e/a0675e (compendium of food additive specifications), Joint FAO/WHO Expert Committee on Food Additives, 67th meeting 2006.
[3] Lujan-Medina GA, Ventura J, Ceniceros AC, Ascacio JA, Valdés DB, Aguilar CN. Karaya gum: General topics and applications. Macromolecules Indian J. 2013; 9:111-6
[4] Goswami S, Naik S. Natural gums and its pharmaceutical application, J. of Scientific and Innovative Research. 2014; 3(1): 112-21
[5] Andrews CN, Storr M. The pathophysiology of chronic constipation, Canadian J. Gastroenterology. 25(Suppl B) 2011: 16B-21B
[6] Sharma A, Rao S. Constipation: pathophysiology and current therapeutic approaches. Gastrointestinal Pharmacology. 2016: 59-74 11. [CrossRef]
[7] Kahrilas PJ. GERD pathogenesis, pathophysiology, and clinical manifestations, Cleveland Clinic J. medi. 2003; 70(5): S4. [CrossRef]
[8] Brady WM. Gastroesophagal reflux disease. Drugs of Today. 1998; 34(1): 25-30.
[9] Wald A. Diagnosis and management of fecal incontinence. Current gastroenterology reports. 2018; 20(3): 1-7 [CrossRef]
[10] Cummings JH. Constipation, dietary fibre and the control of large bowel function. Postgraduate Medi. J. 1984; 60(709): 811. [CrossRef]
[11] Kraemer M.Magnesium trisilicate NNR Its position among antacids used to treat peptic ulcer. The American J. Digestive Diseases. 1941; 8(2): 56-9. [CrossRef]
[12] Kantor JL. Antacid gastric therapy, with especial reference to the use of neutral antacids. J. American Medi. Association. 1923; 81(10): 816-8. [CrossRef]
[13] Ikarashi N, Mimura A, Kon R, Iizasa T, Omodaka M, Nagoya C, Ishii M, Toda T, Ochiai W, Sugiyama K. The concomitant use of an osmotic laxative, magnesium Sulphate, and a stimulant laxative, bisacodyl, does not enhance the laxative effect. Europ. J. Pharmaceutical Sci. 2012; 45(1-2): 73-8. [CrossRef]
[14] Capasso F, Gaginella TS. Natural Laxatives of Mineral Origin, In Laxatives Springer, Milano 1997: 43-45 [CrossRef]
[15] Wardhana YW, Hasanah AN, Primandini PR. Deformation and adsorption capacity of kaolin that is influenced by temperature variation on calcinations. Int. J. Pharm. Pharm. Sci. 2014; 6: 78-5867
[16] Schiller LR. Antidiarrheal drug therapy. Current Gastroenterology Reports. 2017; 19(5): 18 [CrossRef]
[17] Glazer JL. Management of heatstroke and heat exhaustion. American Family Physician. 2005; 71(11): 2133-40
[19] Anderson DM. Evidence for the safety of gum karaya (Sterculia spp.) as a food additive, Food Additives & Contaminants. 1989; 6(2): 189-99 [CrossRef]
[20] Mukhtar GL, Aminu M, Hayatuddeen MR, Bello I. Prevalence and risk factors associated with rotavirus diarrhea in children less than five years in Katsina State, northwestern Nigeria. Bayero J. of Pure and Applied Sci. 2016; 9(2): 12-16 [CrossRef]
[21] http://www.inchem.org/documents/jecfa/jecmono/v18je09 Karaya gum (WHO Food Additives Series 18, Accessed May 5, 2021.
[22] Figley KD. Karaya gum (Indian gum) hypersensitivity, J. of the American Med. Association. 1940; 114(9):747-8 [CrossRef]
[23] Jani GK, Shah DP, Prajapati VD, Jain VC. Gums and mucilages: versatile excipients for pharmaceutical formulations. Asian J Pharm Sci. 2009; 4(5): 309-23.
[24] British pharmacopoeia. Vol. IV. London: Medicines and Healthcare products Regulatory Agency; 2020. Sterculia gum, 466-467.
[25] British pharmacopoeia. Vol. II. London: Medicines and Healthcare products Regulatory Agency; 2020. Heavy Kaolin; p. 48.
[26] British pharmacopoeia. Vol. II. London: Medicines and Healthcare products Regulatory Agency; 2020. Dried Magnesium Oxide; p. 192
[27] British pharmacopoeia. Vol. II. London: Medicines and Healthcare products Regulatory Agency; 2020. Magnesium Trisilicate; p. 192-193.
[28] Pawar HA, D’mello PM. Development and evaluation of herbal laxative granules, J. Chemical and Pharmaceutical Research. 2011; 3(3): 646-50
[29] Poosarla A, Muralikrishna R. Viscosity, swelling index and moisture content in gum karaya, Inte. J. Sci. and Research. 2015; 6(4): 1189-1192